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Teriflunomide Patent Expiration

Teriflunomide is Used for treating patients with relapsing forms of multiple sclerosis. It was first introduced by Sanofi Aventis Us Llc in its drug Aubagio on Sep 12, 2012. 19 different companies have introduced drugs containing Teriflunomide.


Teriflunomide Patents

Given below is the list of patents protecting Teriflunomide, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Aubagio US9186346

(Pediatric)

 Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients Aug 04, 2034 Sanofi Aventis Us
Aubagio US9186346 Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients Feb 04, 2034 Sanofi Aventis Us
Aubagio US8802735

(Pediatric)

 (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability Mar 14, 2031 Sanofi Aventis Us
Aubagio US8802735 (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability Sep 14, 2030 Sanofi Aventis Us
Aubagio US6794410

(Pediatric)

 Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide for treating multiple sclerosis Mar 12, 2027 Sanofi Aventis Us
Aubagio US6794410 Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide for treating multiple sclerosis Sep 12, 2026 Sanofi Aventis Us
Aubagio US5679709 Medicaments to combat autoimmune diseases Oct 21, 2014

(Expired)

 Sanofi Aventis Us
Aubagio US5459163 Medicament to combat autoimmune diseases Oct 17, 2012

(Expired)

 Sanofi Aventis Us



Teriflunomide's Family Patents

Family Patents

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Teriflunomide Generic API Manufacturers

Several generic applications have been filed for Teriflunomide. The first generic version for Teriflunomide was by Watson Laboratories Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc and was approved on Jul 27, 2018. And the latest generic version is by Torrent Pharma Inc and was approved on Apr 4, 2024.

Given below is the list of companies who have filed for Teriflunomide generic, along with the locations of their manufacturing plants worldwide.


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG

tablet Prescription ORAL AB Jan 7, 2019
7MG

tablet Prescription ORAL AB Jan 7, 2019





2. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
7MG

tablet Prescription ORAL AB Apr 19, 2019
14MG

tablet Prescription ORAL AB Apr 19, 2019


Manufacturing Plant Locations
New

Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.

Country City Firm Name
India
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd
Panchmahal Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Vadodara Alembic Pharmaceuticals, Ltd
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)





3. AMNEAL PHARMS CO

Amneal Pharmaceuticals Co Gmbh has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Amneal Pharms Co.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG

tablet Discontinued ORAL N/A Sep 28, 2018
7MG

tablet Discontinued ORAL N/A Sep 28, 2018





4. APOTEX

Apotex Inc has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
7MG

tablet Prescription ORAL AB Nov 2, 2018
14MG

tablet Prescription ORAL AB Nov 2, 2018


Manufacturing Plant Locations
New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Brantford Apotex Pharmachem Inc.
Winnipeg Apotex Fermentation Inc.
Etobicoke Apotex, Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.
Toronto Apotex Inc.
India
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bengaluru Apotex Research Private Limited
Bangalore Apotex Pharmachem India Pvt Ltd.





5. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG

tablet Prescription ORAL AB Oct 26, 2018
7MG

tablet Prescription ORAL AB Oct 26, 2018


Manufacturing Plant Locations
New

Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd
Sangareddy Aurobindo Pharma Limited
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





6. BIOCON PHARMA

Biocon Pharma Ltd has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Biocon Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
7MG

tablet Prescription ORAL AB Mar 13, 2023
14MG

tablet Prescription ORAL AB Mar 13, 2023


Manufacturing Plant Locations
New

Biocon Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Biocon Pharma as present at those locations.

Country City Firm Name
India
Bengaluru Biocon Pharma Limited





7. BRECKENRIDGE

Breckenridge Pharmaceutical Inc has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Breckenridge.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG

tablet Discontinued ORAL N/A Sep 24, 2021
7MG

tablet Discontinued ORAL N/A Sep 24, 2021


Manufacturing Plant Locations
New

Breckenridge's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Breckenridge as present at those locations.

Country City Firm Name
United States
Boca Raton Breckenridge Pharmaceutical, Inc.
Berlin Breckenridge Pharmaceutical, Inc





8. GLENMARK SPECLT

Glenmark Specialty Sa has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Glenmark Speclt.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG

tablet Prescription ORAL AB Nov 15, 2018
7MG

tablet Prescription ORAL AB Nov 15, 2018





9. HETERO LABS LTD V

Hetero Labs Ltd Unit V has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd V.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG

tablet Prescription ORAL AB Mar 13, 2023
7MG

tablet Prescription ORAL AB Mar 13, 2023





10. MSN

Msn Laboratories Private Ltd has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Msn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG

tablet Prescription ORAL AB Apr 24, 2019
7MG

tablet Prescription ORAL AB Apr 24, 2019


Manufacturing Plant Locations
New

Msn's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Msn as present at those locations.

Country City Firm Name
India
Yadadri Bhuvanagiri District MSN Organics Private Limited
Medak MSN LIFE SCIENCES PRIVATE LIMITED
Sangareddy MSN Laboratories Private Ltd.
Rangareddy District MSN Laboratories Private Limited
Isnapur MSN Laboratories Private Limited, Unit-II
Jinnaram, Sangareddy MSN Laboratories Private Limited - Formulations Division
Rangareddy District MSN Laboratories Private Limited (Formulations Division, Unit-II)
Sangareddy MSN Laboratories Private Limited, R&D Center
Sangareddy MSN Pharmachem Private Limited
Kamareddy MSN Life Sciences Private Limited
United States
Piscataway MSN PHARMACEUTICALS INC





11. MYLAN

Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
7MG

tablet Discontinued ORAL N/A Feb 28, 2020
14MG

tablet Discontinued ORAL N/A Feb 28, 2020


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
San Carlos Mylan Pharmaceuticals Inc.
Rockford Mylan Institutional, Inc.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
Morgantown Mylan Specialty, L.P.
Greensboro Mylan Pharmaceuticals Inc
Saint Albans Mylan Technologies, Inc.
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
India
Sinnar Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Hosur Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Hyderabad Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Anekal Taluk, Bangalore Mylan Laboratories Limited
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





12. NATCO

Natco Pharma Ltd has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Natco.

Strength Dosage Form Availability Application Pathway TE code Launch Date
7MG

tablet Prescription ORAL AB May 15, 2023
14MG

tablet Prescription ORAL AB May 15, 2023


Manufacturing Plant Locations
New

Natco's manufacturing plants are situated in 2 countries - United Kingdom, India. Given below are the details of these plant locations as well as the firm names of Natco as present at those locations.

Country City Firm Name
United Kingdom
Buckingham Natco Foods Ltd
Hayes Natco Cash and Carry
India
Hyderabad NATCO PHARMA LTD
Paravada Natco Pharma Limited
Hyderabad Natco Pharma Limited
Chennai NATCO Pharma Limited Chemical Division Chennai
Rangareddy District Natco Pharma Ltd. - Chemical Division
Rangareddy NATCO Pharma Limited





13. SANDOZ

Sandoz Inc has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
7MG

tablet Prescription ORAL AB Jan 3, 2019
14MG

tablet Prescription ORAL AB Jan 3, 2019


Manufacturing Plant Locations
New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country City Firm Name
Austria
Kundl Sandoz GmbH
Langkampfen Sandoz GmbH
United States
Princeton Sandoz Inc
East Hanover Sandoz Incorporated
Spain
Palafolls Sandoz Industrial Products, S.A.
Les Franqueses Del Valles Sandoz Industrial Products S.A.
India
Navi Mumbai Sandoz Private Limited





14. SOLA PHARMS

Sola Pharmaceuticals has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Sola Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG

tablet Prescription ORAL AB Jun 17, 2020
7MG

tablet Prescription ORAL AB Sep 28, 2023





15. TEVA PHARMS USA

Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG

tablet Prescription ORAL AB Sep 4, 2018
7MG

tablet Prescription ORAL AB Sep 4, 2018





16. TORRENT

Torrent Pharma Inc has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Torrent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG

tablet Discontinued ORAL N/A Apr 4, 2024
7MG

tablet Discontinued ORAL N/A Apr 4, 2024


Manufacturing Plant Locations
New

Torrent's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Torrent as present at those locations.

Country City Firm Name
India
Bharuch Torrent Pharmaceuticals Limited
Pithampur Torrent Pharmaceuticals Limited
Indrad Torrent Pharmaceuticals Limited
Gandhi Nagar Torrent Pharmaceuticals Limited
Thanam Torrent Pharmaceuticals Limited
United States
Kalamazoo Torrent Pharma Inc.
Basking Ridge Torrent Pharma Inc.





17. WATSON LABS TEVA

Watson Laboratories Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Watson Labs Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
7MG

tablet Discontinued ORAL N/A Jul 27, 2018
14MG

tablet Discontinued ORAL N/A Jul 27, 2018





18. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
7MG

tablet Prescription ORAL AB Nov 30, 2018
14MG

tablet Prescription ORAL AB Nov 30, 2018